Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR THE ESTIMATION OF APREMILAST BY FORCED DEGRADATION STUDIES

N. A. Lonkar* and Dr. S. D. Sawant, M. N. Dole

ABSTRACT

The present work describes development and validation of a simple, sensitive, precise, accurate and specific stability-indicating high performance liquid chromatographic method of analysis of Apremilast, as bulk drug. The separation was achieved by using a mobile phase of methanol: water (70:30, v/v) on a C18 column (250mm x 4.6ID, 5μm) at flow rate of 0.8 ml/min. The detection was done at 230 nm. The retention time of Apremilast was 5.203 minutes. Apremilast was subjected to stress conditions of acidic, alkaline, oxidation, photolytic and thermal degradation. The degraded products were well resolved from the pure drug with significantly different retention time values. Linearity was found to be in the range of 10-50 μg/ml with significantly high value of correlation coefficient. The method was validated for linearity, accuracy, precision, robustness and recovery. The limits of detection and quantitation were 0.5329μg/ml and 1.615μg/ml respectively.

Keywords: Apremilast, RP-HPLC, Forced degradation, Validation.